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CAR T-cell Therapy
CTX112 for B-Cell Cancers
Phase 1 & 2
Recruiting
Research Sponsored by CRISPR Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from ctx112 infusion up to 60 months post-infusion
Awards & highlights
Study Summary
This trial is testing a new drug for people with hard-to-treat B-cell cancers, to see if it's safe and effective.
Who is the study for?
Adults over 18 with certain B-cell cancers that have come back or didn't respond to treatment can join. They must be fairly active and healthy, with good heart, kidney, liver, and lung function. Participants need to use birth control during the trial and for a year after getting the study drug.Check my eligibility
What is being tested?
The trial is testing CTX112's safety and effectiveness in patients with various types of B-cell malignancies that are resistant or have relapsed. It's an early-phase study where everyone gets the same experimental therapy.See study design
What are the potential side effects?
Specific side effects of CTX112 aren't listed here but may include typical reactions related to immune therapies such as fatigue, fever, chills, weakness, infection risk increase, nausea or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from ctx112 infusion up to 60 months post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from ctx112 infusion up to 60 months post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Phase 2 (Cohort Expansion): Objective response rate
Secondary outcome measures
Duration of Clinical Benefit (DOCB)
Duration of Response
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CTX112Experimental Treatment1 Intervention
Administered by IV infusion following lymphodepleting chemotherapy.
Find a Location
Who is running the clinical trial?
CRISPR Therapeutics AGLead Sponsor
8 Previous Clinical Trials
772 Total Patients Enrolled
Sarah Cohen, MDStudy DirectorCRISPR Therapeutics
2 Previous Clinical Trials
253 Total Patients Enrolled
Annie Weaver, PhDStudy DirectorCRISPR Therapeutics
2 Previous Clinical Trials
253 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant from a donor.I have an ongoing serious infection needing IV treatment.My kidney, liver, heart, and lung functions are all good.I am not pregnant or breastfeeding.I am 18 years old or older.My B cell cancer has returned or is not responding to treatment.I do not have active HIV, hepatitis B, or hepatitis C.I am fully active or can carry out light work.I haven't taken any cancer drugs or been in a trial for at least 14 days or 5 half-lives.My cancer has affected or previously affected my brain or spinal cord.I have had cancer before, but it was either skin cancer treated by surgery, cervical in situ carcinoma, or any cancer in remission for 5+ years.I have an immune system disorder or autoimmune disease and need steroids or other immune-suppressing drugs.I have a history of seizures, stroke, memory disorders, balance issues, or autoimmune disease affecting my brain.I agree to use birth control from enrollment through 12 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CTX112
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any opportunities for individuals to participate in the experiment?
"Affirmative. The clinical trial, which was originally posted on March 10th 2023 and most recently modified on March 30th 2023, is looking for 120 people among two different sites according to the data hosted by clinicaltrials.gov."
Answered by AI
What is the current enrollment count of this research trial?
"Affirmative. The clinicaltrials.gov platform states this study is actively recruiting volunteers, which was first announced on March 10th 2023 and recently revised on the 30th of that same month. This trial requires 120 patients to be enrolled from two different sites."
Answered by AI
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